Currently, there is almost an epidemic of cancer; at least some of which is thought to be either caused or exacerbated by foods having a hormonal supplement derived from an animal origin. This is thought especially true for breast and prostate cancer. Other forms of cancers which are of special concern are skin cancer, colon cancer, urinary cancer, cancer of the bladder and the like.
It is thought that many of those cancers, especially breast and prostate cancers, are either preventable or treatable by a use of phytochemical fractions, especially isoflavones, as a source of supplemental hormones, and particularly if such use begins before a female reaches puberty. For males, apparently the treatments may begin at any time.
However, it is also thought that there are superior results when a plurality of such phytochemical fractions are consumed in combinations which are tailored to have a profile to treat or prevent such cancers. A proper diet should contain the desired phytochemical fractions. Many people do not have or do not like the kind of proper diet which provides the desirable effects. Hence, the challenge is to furnish the necessary phytochemical fractions in a form which is more acceptable. This is achieved in the present invention by a refining process which enables extraction, refining, isolation, and selection of specific phytochemical fractions which are combined and tailored to the needs of specific illnesses, particularly cancers.
Another object of this invention is to provide an optimized extract composition of phytochemical fractions which are present in sufficient concentration to be delivered at the proper dosage in an easy to consume form such as a pill, tablet, capsule, liquid or ingredient in a food including health bars.
This extract may be used alone or combined with one or more other plant extracts to produce the optimized composition. Further, this extract composition may be formulated with one or more other dietary nutrients, such as vitamins, minerals, amino acids, etc., to provide a nutritional supplement further optimized for a desired health effect. All of these ingredients may be combined with necessary binders, excipients, preservatives, colors and the like known to those in the industry in order to produce a suitable tablet, capsule, pill, liquid, cream, powder or food ingredient in a food including health bars.
The improved composition is obtained by fractionating a plant source high in isoflavones, lignans and other phytochemicals such as defatted soybean flakes, soy molasses, soy whey, red clover, alfalfa, flax, cocoa, tea, or kudzu root. These may be fractionated alone or in combination with these other plants known to be high in the various isoflavones, lignans, saponins and saponogenins, catechins and phenolic acids. The fractionation results in substantially removing water, carbohydrates, proteins, and lipids from the source material. The fractionation method may be preferably that disclosed in U.S. Pat. Nos. 5,702,752, 6,261,545; 6,017,555; 6,033,714 or 4,428,876, or an extraction using ethyl acetate or n-butanol may be used. U.S. Pat. Nos. 5,702,752; 6,017,555; 6,033,714; 6,261,545 are assigned to the assignee of this invention.
TABLE 1Ingredients of experimental diets (grams)Diet 1Diet 2Diet 3Diet 4Diet 5Diet 6caseinSPICasein/LSPCSPI/LSPCCasein/HSPCSPI/HSPSPI020002000200Casein200020002000DL-methionine333333Corn starch150150150150150150Sucrose500500500500500500Cellulose, BW200505050505050Corn oil505050505050Mineral Mix. S10011353535353535Vitamin Mix. V10011101010101010Choline Bitartrate222222Soy phytochemicals00221010Total (g)100010001002100210101010(isoflavones, mg/kg diet)02453415867059501AIN formulation with minor modification by Dr. E. A. Ulman, Research Diets, Inc 
TABLE 2Final body weight, total food intake, total isoflavone intake, and tumor volumeFood intakeTumor volumeTreatmentBody weightgrams/mTotal isoflavone(cm3)Casein22.4 ± 0.5146.6 ± 3.1 0.00 ± 0.002.32 ± 0.312SPI23.1 ± 0.746.2 ± 2.817.00 ± 6.372.06 ± 0.32Casein/LSPC21.4 ± 0.741.2 ± 3.414.03 ± 141.88 ± 0.35SPI/LSPC22.6 ± 0.650.1 ± 4.729.36 ± 2.761.66 ± 0.29*Casein/HSPC22.2 ± 0.744.8 ± 6.176.38 ± 10.401.64 ± 0.22*SPI/HSPC22.0 ± 0.647.5 ± 1.792.53 ± 3.221.39 ± 0.30**1Values are means ± SE. There are no significant differences of food intake or body weight among treatment groups. 2Compared with control group, SPI/LSPC. casein/HSPC, and SPI/HSPC had significantly smaller tumor volumes (*:p < 0.04; **:p < 0.005). 
TABLE 3Effects of treatment on apoptotic index (AI, % TUNEL),proliferation index (PI, % PCNA Staining) andangiogenesis (microvessel density)TreatmentAI (% TUNEL)PI (% PCNA)Microvessel DensityControl (n = 2) 6.07 ± 0.8860.1 ± 1.112.5 ± 3.8Casein/HSPC10.75 ± 0.5451.7 ± 1.3 9.7 ± 0.7(n = 2)P value<0.02<0.01>0.05Values are means ± SE. 
In summary, preliminary results indicate that soy products inhibit the s.c. growth of LNCaP tumor in SCID mice, possibly via induction of apoptosis, and inhibition of angiogenesis and proliferation.
Isoflavones or lignans can alleviate menopausal-related symptoms such as hot flashes and osteoporosis as well as alleviate symptoms associated with menstruation. This is further believed to be due to their estrogenic activity. It is believed that the improved composition described here will alleviate these symptoms even more effectively.
Also, isoflavones positively affect various cardiovascular-related conditions, including heart disease, cholesterol (saponins also positively affect cholesterol), angiogenesis and other vascular effects. It is believed that the improved composition will produce results for these cardiovascular conditions at least as beneficial as those hitherto known and at a reduced cost.
As explained earlier, isoflavones, lignans, and saponins are known to individually positively affect various neurological and immunological symptoms. It is believed that the improved composition will result in alleviating neurological and immunological symptoms at least as well as those compounds hitherto known and at a reduced cost. Moreover, it would be expected that some synergism would arise out of the combination described herein.
The improved composition may be administered orally, parenterally, for instance, subcutaneously, intravenously, intramuscularly, intraperitoneally, by intranasal instillation or by application of an aerosol spray to mucous membranes, or to the skin by an ointment or a cream.
Administering the improved composition may be done with any suitable carrier, in solid or liquid dosage form such as tablets, capsules, powders, soft gels, solutions, suspensions, emulsions, ointments, or creams. The improved composition may also be administered as a food supplement or as a food ingredient.
The amount of the improved composition administered will vary depending on the person, the mode of administration, and the desired result. An effective amount is expected to be 10 mg to 2000 mg/per dose.